Kornimate/medical-research-clean huggingface dataset:
a study evaluating efficacy and safety of elexacaftor/tezacaftor/ivacaftor in subjects 6 through 11 years of age with cystic fibrosis and f/mf genotypes

Conditions: Cystic Fibrosis

Summary: this study will evaluate the efficacy and safety of elexacaftor (elx) / tezacaftor (tez) / ivacaftor (iva) triple combination (tc) in subjects 6 through 11 years of age with cystic fibrosis (cf) who are heterozygous for f508del and a minimal function (mf) mutation (f/mf genotypes).


Eligibility criteria:
key inclusion criteria: * heterozygous for the f508del mutation (f/mf) * forced expiratory volume in 1 second (fev1) value greater than equal to(≥) 70% key exclusion criteria: * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status * solid organ or hematological transplantation other protocol defined inclusion/exclusion criteria may apply
dialysate sodium lowering trial

Conditions: Hemodialysis Complication; Fluid Overload; Dialysis Disequilibrium; Intra-dialytic Hypotension; Hypertension

Summary: this is a pilot randomized clinical trial in which patients treated with 3x per weekly conventional hemodialysis will be treated to a dialysate sodium 135 meq/l vs. 138 meq/l and followed for safety and tolerability, effects on bp and volume.

this is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (na) of 135 meq/l or a standard dialysate na of 138 meq/l. patients will be randomized 2:1 to the low arm. dialysate na will be lowered 1 meq/l every 2 weeks, as tolerated. tolerance will be assessed by symptoms, intradialytic hypotension (idh) episodes (systolic bp \<90 or intervention for symptoms or bp drop during dialysis), achievement of dry weight. the trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. the primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).

Eligibility criteria:
inclusion criteria: * age \>18 years * patients undergoing thrice weekly in-center conventional hd * at least 90 days since start of hemodialysis * absence of pulmonary edema / signs of fluid overload on physical exam * currently dialyzing at a dna \>=137 meq/l * single session kt/v \>=1.3 each month for the past 2 months * hypertensive, defined by a pre-dialysis bp of \>140/90 or treatment with 1 or more antihypertensive agents * no more than 1 skipped treatment and no more than 1 session per month shortened by \>10 min * life expectancy \>12 months * able to provide informed consent * speaks and understands english exclusion criteria: * prone to idh, defined as idh occurring in \>10% of treatments in the past 3 months. idh will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic bp \<90 mm hg and/or use of intervention(s) (uf goal lowered, treatment stopped early, or saline given) because of idh * pregnancy

Keywords: hemodialysis fluid overload dialysis disequilibrium intra-dialytic hypotension dialysate sodium lowering
cell responses to ifn-gamma

Conditions: Plaque Psoriasis

Summary: ifn-gamma is a central player in the development of psoriasis lesions, which can be involved a variety of cellular processes in the skin. dendritic cells are important cells in driving inflammation in psoriasis through the induction of t cells that produce il-17 in psoriasis. injecting ifn-g into the skin can increase the numbers of t cells and also inflammatory dcs that produce cytokines involved in il-17 production. thus, the investigators hypothesize that the dendritic cells present in the skin after ifn-g injection polarize il-17-producing t cells.


Eligibility criteria:
inclusion criteria: * signed informed consent * normal volunteers with no evidence of skin disease or diagnosis of plaque type psoriasis for at least 6 months * 18 years of age or greater * for women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study. acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, iud, female condom, diaphragm with spermicide, cervical cap; or a sterile sexual partner exclusion criteria: * guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis * clinically significant psoriasis flare during screening or on the first treatment day * hypersensitivity to ifn-g or e. coli derivatives * pre-existing, uncontrolled myelosuppression, cardiac disease, seizure disorders, compromised central nervous system function or multiple sclerosis * history of malignancy, clinically significant renal insufficiency, poorly controlled medical conditions that would increase the risks * presence of malignancy within the past 5 years, including lymphoproliferative disorders. subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled. * pregnancy or lactation. as the risk of ifn-g in pregnancy is unknown, pregnant women will be excluded from the study. * any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug

Keywords: psoriasis
chemoembolization for lung tumors

Conditions: Lung Metastases; Endobronchial Metastases; Pleural Metastases; Mediastinal Metastases

Summary: this study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.


Eligibility criteria:
inclusion criteria: * lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or sbrt. * at least 18 years old. * ecog performance status 0 or 1 exclusion criteria: * primary lung cancer * \>50% of a lung is replaced with tumor * oxygen saturation \<92% on room air * fev1 \<60% * pulmonary hypertension (diagnosed or suspected on echocardiography, ct, mri, or direct pressure measurement) * recent pulmonary embolism (within 3 months) * pulmonary arteriovenous malformation * active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month) * symptomatic heart failure (dyspnea, volume overload) * left bundle branch block (contraindication to pulmonary angiography) * renal failure (egfr \<30 ml/min/1.73m\^2) * pregnancy * breastfeeding * altered mental status that would interfere with consent or follow-up * platelets \< 100,000 (after transfusion, if needed) * inr\>2 (after transfusion, if needed) * hemoglobin \<7 (after transfusion, if needed) * hyperthyroidism (contraindication to lipiodol) * planned radioactive iodine imaging or therapy (contraindication to lipiodol) * allergy to lipiodol or mitomycin * allergy to iodinated contrast that can not be treated with steroid / diphenhydramine premedication * any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

Keywords: unresectable lung cancer unresectable endobronchial mestastases unresectable pleural metastases unresectable mediastinal metastases lung chemoembolization 19-371 memorial sloan kettering cancer center
a study to evaluate eciskafusp alfa in combination with bacillus calmette-guerin (bcg) in participants with bcg-unresponsive high-risk non-muscle invasive bladder cancer (nmibc)

Conditions: Non-muscle Invasive Bladder Cancer

Summary: the study aims to establish the safety, tolerability, pharmacokinetics (pk), relevant biomarkers, pharmacodynamics (pd) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with bcg in participants with bcg-unresponsive high-risk nmibc. the study plans a similar evaluation of eciskafusp alfa in monotherapy following a positive interim analysis of the combination therapy.


Eligibility criteria:
inclusion criteria: * pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to world health organization (who) grading system * absence of resectable disease after transurethral resection of bladder tumor (turbt) procedures * the most recent cystoscopy/turbt must have been performed within 12 weeks and up to 14 days of the first dose of study treatment * presence of bcg-unresponsive disease defined as persistent or recurrent carcinoma in situ \[cis\] (± recurrent ta/t1 disease) within 12 months of receiving adequate bcg therapy * the participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure. * negative hepatitis b surface antigen (hbsag) test at screening * positive hepatitis b surface antibody (hbsab) test at screening * negative hepatitis c virus (hcv) antibody test at screening exclusion criteria: * significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders * active infections (both systemic and local urinary) * congenital or acquired immune deficiencies resulting in immunosuppression * known human immunodeficiency virus (hiv) infection * history of radiotherapy of the bladder * history of perforation of the bladder * major surgery or significant traumatic injury within 28 days prior to first administration of study treatment or anticipation of the need for major surgery during treatment * participants currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than bcg, and supportive care therapies for active disease * any intervening intravesical immunotherapy or chemotherapy from the time of the most recent cytoscopy/turbt to the start of study treatment * systemic immune-modulating and systemic immunosuppressive agents/medication * administration of a live, attenuated vaccine within 28 days prior to first administration of study treatment * recurrence of bcg unresponsive cis \> 12 months after last bcg instillation * concurrent second malignancy

Keywords: bcg-unresponsive non-muscle invasive bladder cancer
effectiveness of virtual reality glasses versus white noise on dental anxiety in children with attention deficit/ hyperactivity disorder

Conditions: Dental Anxiety

Summary: the present study aims to assess and compare the effectiveness of distraction technique using virtual reality glasses and white noise with basic behavior guidance techniques on dental anxiety in children with attention deficit/ hyperactivity disorder.


Eligibility criteria:
inclusion criteria: * children diagnosed with adhd according to the dsm-v criteria and diagnosis confirmed by a pediatric neurologist. * all children should be on stimulant medication. * no previous dental experience. * written consent of the legal guardian. exclusion criteria: * children with physical disabilities or other psychiatric disorders. * children with visual or hearing disabilities. * patients requiring emergency treatment
empowering patients on choices for renal replacement therapy (aim 3) (epoch-rrt)

Conditions: Chronic Kidney Disease

Summary: empowering patients on choices for renal replacement therapy (epoch-rrt) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. the inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis. for aim 3, the investigators are going to compare measures related to the decision-making process between patients receiving and not receiving a decision aid focusing on peritoneal dialysis and hemodialysis.


Eligibility criteria:
inclusion criteria: * 18 years and older * speaks english * has access to the internet exclusion criteria:

Keywords: chronic kidney disease hemodialysis peritoneal dialysis
evaluation of medical and nursing management for bronchiectasis

Conditions: Bronchiectasis

Summary: the purpose of this research is to retrospectively evaluate current clinical care of bronchiectasis (non-cystic fibrosis \[cf\]) in adults from a multidisciplinary management perspective. this evaluation aims to address the important gaps in current clinical care in 2011, 2013 and july 2016- jun2017. the primary outcome of this evaluation is to compare the efficacy of current multidisciplinary clinical practice to the british thoracic society (bts) \& thoracic society of australia and new zealand (tsanz) guidelines for bronchiectasis. secondary outcomes of this evaluation will determine the impact of clinical care in 2011, 2013 and july2016-june2017 through quantification of:hospital utilization for using hospital admission data, average length of stay, readmission rates within 28 days, emergency service attendance, outpatient review, exacerbations use of antibiotics, use of hospital and home (h@h), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.

project design: the study will be a 12 month retrospective observational cohort study conducted through a review of medical records, internal respiratory databases and electronic hospital patient record (oacis, homer \& epas). participants: participants in the study will include all patients who have emergency service presentations or admissions to the queen elizabeth hospital (tqeh) with new or existing bronchiectasis in 2011(jan 1st to dec 31st). this will be repeated using the same criteria in 2013. an additional year of july2016- jun2017 has been added for recency of management and to assess if change occurred with introduction of electronic patient record. data collection: demographics, clinical data, hospital service utilization, and clinical outcomes such as exacerbation frequency and disease progression. all data will be extracted into a standardized data extraction form, which a random subset will be checked by a second researcher.analysis of results:demographic and descriptive data will be given in means + standard deviation and compared using a two-tailed and student t-test. categorical variables will be compared using chi-squared or fisher exact tests, and when appropriate the mann whitney u test for non-parametric data. statistical significance will be determined using an alpha of p \<0.05. all analyses will be examined using spss software (version x). a subgroup analysis for primary and secondary admission diagnosis will also be performed.

Eligibility criteria:
inclusion criteria: admission or attendance to emergency services at the queen elizabeth hospital with primary or secondary diagnosis of bronchiectasis in 2011. repeated using same criteria in 2013 and july2016-june2017 exclusion criteria: patients who do not have bronchiectasis. patients with traction bronchiectasis. patients who do not have outpatient follow up. patients who have follow up by private physicians or other hospitals and records are unavailable.

Keywords: disease management best practice guidelines
improvement of fluid balance in patients undergoing surgery of the colon and rectum

Conditions: Colorectal Carcinoma

Summary: 58 patients undergoing surgery of the large bowel are divided into two groups. the control group will receive standard care. the intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. between group differences are measured primarily by markers of intestinal damage in plasma and urine. also co2 pressure in the stomach lumen is measured (reflecting blood supply to the gut). the investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.


Eligibility criteria:
inclusion criteria: * all patients undergoing elective colorectal surgery with anastomosis; * minimum age 18 years; * giving informed consent. exclusion criteria: * other causes of intestinal damage: eg. ibd, occlusive disease; * steroid use; * esophageal varices and other esophageal disease; * aortic valve disease.

Keywords: hemodynamic optimization enhanced recovery after surgery goal-directed fluid
the effects of adrenaline and milrinone in patients with myocardial dysfunction after cabg

Conditions: Cardiac Output, Low

Summary: myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. this prospective, randomized pilot-study analyses the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary-artery-bypass-grafting. with respect to data derived from patients with sepsis shock and results from studies using phosphodiesterase-inhibitors prophylactically, the hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects (hyperlactatemia and hyperglycemia) and renal dysfunction.

following preoperative written informed consent, patients presenting with a cardiac-index (ci) \ 3.0 l/min/m2. a group of patients not needing inotropes will be used as controls. hemodynamics, metabolism (plasma lactate, pyruvate, glucose, acid-base status, insulin requirements) and renal function (urinary excretion of alpha-1-microglobulin, creatinine clearance, plasma cystatin-c levels) will be determined during the treatment period and up to 48 hours after surgery (follow up period). the study is designed as a pilot study including 20 patients per group.

Eligibility criteria:
inclusion criteria: * cardiac index below 2.2 l/min/m2 upon intensive care unit admission despite optimized filling pressures and normalized mean arterial blood pressure (map) after elective coronary artery bypass grafting exclusion criteria: * intraoperative use of diuretics or hydroxyethylstarch

Keywords: coronary artery bypass grafting inotropes metabolism renal failure
hospital processes reengineering of intravenous thrombolysis in acute ischemic stroke in china

Conditions: Ischemic Stroke; Adverse Effect of Thrombolytic Drugs, Sequela

Summary: promise is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on hospital intravenous thrombolysis process reengineering for acute ischemic stroke (ais). with a proposed "reengineered process framework" for intravenous thrombolysis process by the promise study steering committee, about 30 medical centers enters would be recruited nationwide, and each center would include consecutive ais patients with an onset-to-door time (odt) of less than 3.5 h. the investigators hypothesize that the proposed "reengineered process framework" is suitable and feasible for hospitals in mainland of china; the rate of intravenous rt-pa thrombolysis in ischemic stroke patients with an odt of less than 3.5 h would be more than 20% or be increased by 40% as compared with baseline; the proportion of patients with a door-to-needle (dnt) time of less than 60 min would be more than 20%, or be with an increase by ≥ 40% as compared with baseline.

1. after reviewing domestic and international clinical research literature, the promise study steering committee constructed the "reengineered process framework" for intravenous thrombolysis process with business process reengineering theory. the suggested "reengineered process framework" is regarded as feasible and suitable for hospitals in mainland of china. 2. the study period is 12 months, of which the first 3 months is the baseline period. after 3 months, all centers should develop new thrombolytic processes according to the "reengineered process framework". the new processes are gradually implemented since the 4th month with continues care quality improvements. 3. the "reengineered process framework" adopts a form of comprehensive package, proposes unified key points of process reengineering, provides a series of supporting, standardized tools for process management, and establishes a real-time key performance indicator (kpi) monitoring feedback system, etc. 4. supporting, standardized tools includes: rapid identification tools of suspected stroke for medical personnel in the emergency system; stroke team building programs; real-time feedback form of kpi; standardized thrombolysis informed consent form and informed conversation public service advertising posters; suggested indications and contraindications for intravenous thrombolysis; standard operation procedure of intravenous rt-pa thrombolysis, etc. with these methods, it is expected to raise the thrombolytic rate for patients arrived at medical center within 3.5 hours after the onset, and to shorten the door to needle time in china.

Eligibility criteria:
inclusion criteria: * all ais patients with an onset-to-door time of less than 3.5 h of onset; informed consent exclusion criteria: 1. complete remission of symptoms and signs, in consideration for patients with transient ischemic attack; 2. silent cerebral infarction without symptoms or signs;

Keywords: acute ischemic stroke intravenous rt-pa thrombolysis process reengineering door-to-needle time
basun - risks for malnutrition, metabolic bone disease and impaired oral health after obesity treatment

Conditions: Obesity, Morbid

Summary: weight-reducing obesity surgery (os) generally gives good results but complications are common; e.g. impaired weight loss, weight regain, bowel pain, diarrhea, vitamin/mineral deficiency, osteoporosis and impaired dental health. the basun study is a prospective 10-year comparison of 1000 surgically and 400 conventionally treated individuals regarding adverse side-effects, risk factors for complications and poor outcome.

the use of obesity surgery (os) has increased dramatically due to the lack of effective conventional weight reducing methods. os generally gives a sustained weight reduction and improves metabolic co-morbidities but complications are not uncommon, e.g. weight regain, bowel pain, diarrhea, vitamin/mineral deficiency, osteoporosis and impaired dental health. studies of os regarding adverse side-effects, risk factors for complications and poor outcomes are few or missing. the basun study is a prospective 10-year comparison of 1000 surgically and 400 conventionally treated individuals. inclusion started in april 2015 and will be completed in 2017. subjects are consecutively included from the whole western region of sweden and are followed by detailed checkups at 2, 5 and 10 years. protocol includes nutritional and bone status, oral health, psychiatric health, gi symptoms, socioeconomics and health economy. data are collected by interviews, blood and fecal samples, questionnaires, dual energy x-ray absorptiometry, dentist examinations, patients' record and registries. the study is carried out in close cooperation with experts in surgery, medicine, psychiatry, endocrinology, gastroenterology, hematology, molecular biology, osteoporosis, oral medicine, physiology and general medicine. the basun study will be able to form the basis for more individualized medical guidelines with the objective of improving therapeutic quality and the utilization of health care resources.

Eligibility criteria:
inclusion criteria: * all patients eligible for obesity treatment under specialist care with medical methods or with surgery exclusion criteria: * no ability to speak, read or write in swedish

Keywords: bariatric surgery gastric bypass malnutrition bone disease oral health